Simple & Safe Implantable Device for Treatment of Gastroesophageal Reflux Disease

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DESCRIPTION (provided by applicant): The ultimate goal of this project is to develop a simple laparoscopic product (Partial Cuff) to treat gastroesophageal reflux disease (GERD) or acid reflux. Of the 40 million U.S. GERD sufferers currently manage their symptoms by life-time medications, at least 4.5 million will require additional or alternative remedies, while another 4 million are not satisfied with their medication regimen. Though fundoplication surgery is the only cure, its severity, risks and physiological perturbations are barriers to adoption by over 99% of patients. GERD represents the most expensive of all of the GI diseases, with over $6 billion spent annually just in prescription medications alone, and this number is growing. Because of the size of this market, many less invasive and mostly trans-oral endoscopic procedures have been developed by large and small companies. They aim to achieve the same objective as surgery in increasing the constraints of the lower esophageal sphincter (LES). Most of these procedures represent significant technical challenges with less than satisfactory clinical outcomes and none of them have been widely adopted. Partial Cuff is designed to be placed laparoscopically, simply and directly onto the esophagus with a click of its special placement handle, thereby circumventing the cumbersome surgery of wrapping a segment of the stomach over the esophagus. Once applied, the shaped and flexible Partial Cuff hugs the esophagus and imparts an immediate constraint over a portion of the LES similar to the Toupet partial fundoplication procedure. This allows the unconstrained portion of the LES still be able to open naturally, such as during swallowing or burping. When tissue ingrowth completes in about 8 weeks, the Partial Cuff becomes integral in the LES wall, further imparting its constraining utilit. This simple and direct treatment procedure minimizes challenges plaguing current surgeries and trans- oral procedures. The proposed Partial Cuff is to improve the quality of life and mitigate life-long dependence on medications for millions of GERD sufferers. This in turn will result in a substantial reduction in national healthcare costs. For Phase I, we propose to advance our concept to working devices. They will be tested on a bench top model and in an in vivo pigs study to verify the working hypothesis, assess biocompatibility and whether the device stays in place. Preliminary work has been completed on the anatomy and pathophysiology of the LES including a finite element analysis on an analogous model of urethral incontinence. The three parts of the device system will be engineered, made, assembled and tested as stated above. Completing this Phase I will allow us to further validate this in a clinical feasibility stuy and to fulfill requirements towards FDA allowance in Phase II.